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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Digital Image Storage, Radiological
510(k) Number K923680
Device Name ELTRAX OPTICAL DISK IMAGE ARCHIVING SYSTEM
Applicant
Minnetonka Medical
8990 Springbrook Dr.
Suite 110
Minneapolis,  MN  55433
Applicant Contact PATRICK J OVEN
Correspondent
Minnetonka Medical
8990 Springbrook Dr.
Suite 110
Minneapolis,  MN  55433
Correspondent Contact PATRICK J OVEN
Regulation Number892.2010
Classification Product Code
LMB  
Date Received07/22/1992
Decision Date 10/20/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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